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Clinical Trials/NCT01849900
NCT01849900
Unknown
Not Applicable

Efficacy Study of the Preconception Reproductive Knowledge Promotion Intervention

Calvin College1 site in 1 country120 target enrollmentFebruary 2013
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Calvin College
Enrollment
120
Locations
1
Primary Endpoint
Change from baseline reproductive knowledge of ovulation, menstrual cycle, peak fertile times, and early signs of pregnancy.
Last Updated
9 years ago

Overview

Brief Summary

This study examines the efficacy of the "Preconception Reproductive Knowledge Promotion (PREKNOP)" intervention, designed to promote women's reproductive health and positive pregnancy outcomes. The study's goal is to educate low-income women about reproductive changes related to their menstrual cycle. The main hypothesis of the study is that women who receive the PREKNOP intervention will report reduced risk of unplanned pregnancy and increased reproductive knowledge, self-efficacy about that knowledge, and pregnancy planning ability.

Detailed Description

This study is a randomized, controlled trial of the PREKNOP intervention in a sample of 120 women 18-44 years old. Teams of nursing students and community health workers will administer the 12-month intervention. In addition to 10 home visits during which women will receive information on the female reproductive system and the expected monthly cyclical changes, PREKNOP will consist of use of ovulation test kits, a 12-month menstrual calendar, a digital thermometer, and educational brochures covering: the female reproductive anatomy, hormones and menstrual cycle, how to recognize ovulation period, various methods of birth control and how they work, and early pregnancy symptoms.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
June 30, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Calvin College
Responsible Party
Principal Investigator
Principal Investigator

Adejoke Ayoola

Dr.

Calvin College

Eligibility Criteria

Inclusion Criteria

  • low-income women of childbearing age

Exclusion Criteria

  • Menopause
  • Hysterectomy

Outcomes

Primary Outcomes

Change from baseline reproductive knowledge of ovulation, menstrual cycle, peak fertile times, and early signs of pregnancy.

Time Frame: Baseline, 3, 6, 12, 18 and 24 months

The investigators will measure if there is an increase in reproductive knowledge of ovulation time, menstrual cycle, peak fertile times, and early signs of pregnancy among the 120 participants in the study. The investigators will compare if there is higher increase in knowledge among the intervention group compared to the 60 participants in control group.

Secondary Outcomes

  • Change from baseline number of unplanned pregnancies(Baseline, 3 months, 6 months, 12 months, 18months, 24 months)

Study Sites (1)

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